STAT

FEBRUARY 3, 2025

The story of how the food industry went gaga for gluten-free products, putting the health of people with celiac at risk in the process, takes center stage in Emily Abel’s new book, “Gluten Free for Life: Celiac Disease, Medical Recognition, and the Food Industry.”

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Grocery Stores Labelling FDA 111

Fierce Pharma

APRIL 30, 2024

Federal Trade Commission (FTC) is not done with its crackdown on what it views as improper listing of patents with the FDA. | FTC is not done with its crackdown on what it views as improper listing of patents in the FDA Orange Book.

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FDA 109

The FDA Law Blog

SEPTEMBER 19, 2023

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Last week, the FTC held a Listening Session about the listing of patents in the Orange Book, which concluded with a unanimous vote to issue a Policy Statement.

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STAT

OCTOBER 1, 2024

lawmaker is pushing the Food and Drug Administration to provide more guidance on listing patents for drug-and-device combination products, such as asthma inhalers and auto-injectors for diabetes treatments, in a highly important agency registry known as the Orange Book. In a letter dated Monday, Sen. Bill Cassidy (R-La.) Bill Cassidy (R-La.)

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FDA 101

The FDA Law Blog

MARCH 26, 2024

Koblitz — The FTC appears to be on a mission to cleanse the Orange Book of patents it deems improperly listed. For the second time in recent years, the FTC has filed an Amicus Brief explaining exactly which patents should not be in the Orange Book.

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The FDA Law Blog

APRIL 7, 2025

Karst will speak at a session, titled Hitting the Books: Examining Orange and Purple Book Delisting from a Patent Prosecutorial Perspective, along with co-presenters Kim Braslow (Senior Director, IP and Government Affairs, AstraZeneca) and Nicole Woods (Associate Vice President, Assistant General Patent Counsel, Eli Lilly and Company).

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FDA 59

Pharmacy Times

NOVEMBER 6, 2022

Beth Macy, author of New York Times-bestselling book Dopesick and executive producer and writer on the Hulu series “Dopesick,” explains how FDA-approved drugs that treat opioid use disorder still aren’t getting into the hands of patients who need it most.

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FDA 123

STAT

SEPTEMBER 14, 2023

In explaining its new policy statement , the FTC noted that some drug companies have failed to follow requirements for listing patents in the so-called Orange Book in hopes of thwarting competition from lower-cost generic medicines. Continue to STAT+ to read the full story…

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Generic Medicine Pharmaceutical Companies Pharmaceutical Companies FDA 113

Fierce Pharma

DECEMBER 21, 2023

Federal Trade Commission's recent crackdown on "improper" patents in the FDA's Orange Book, GSK, Amneal and Kaleo have made the requested changes. Following the U.S. Following the U.S.

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FDA 78

STAT

MAY 13, 2024

Today we learn whether AI might help hasten the development of n-of-1 therapies (hint: not yet), explore why the FDA hasn’t offered Orange Book guidance on drug-device combinations, and talk about CRISPR.   Sign up  to get our biotech newsletter in your inbox. Read the rest…

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FDA 97

pharmaphorum

MARCH 14, 2022

AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic rhinosinusitis in people with nasal polyps, after the FDA rejected its marketing application. Sanofi – which books Dupixent sales – reported it made $5.7 billion from the drug last year. billion for GSK last year.

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FDA 116

pharmaphorum

MARCH 25, 2022

The FDA has given ViiV healthcare and Johnson & Johnson a boost in the market for long-acting injectable HIV drugs, approving a new regimen for their Cabenuva product that does away with the need for an oral lead-in period. The post ViiV, J&J get FDA nod for simpler HIV injectable dosing appeared first on.

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Fierce Pharma

NOVEMBER 7, 2023

Only two months after the Federal Trade Commission said it was eying a crackdown on improper patents listed by the FDA, the agency has filed challenges against more than 100 patents in the agency's Orange Book. Pharma, you were warned. The companies have 30 days to respond.

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FDA 101

STAT

SEPTEMBER 30, 2022

When does the FDA call in security? Then, oncologist Mikkael Sekeres joins us to talk about his new book, which is a history of the FDA and an insider’s look at one of the agency’s most contentious drug approval hearings. Does the latest Alzheimer’s disease drug actually work? Read the rest…

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FDA 76

pharmaphorum

JANUARY 25, 2022

The FDA has limited the use of COVID-19 antibody therapies developed by Eli Lilly and Regeneron, on the back of data suggesting they have are “highly unlikely” to be effective against the now-dominant Omicron variant. billion sales for its COVID-19 antibodies in the first nine months of 2021, while Regeneron booked a whopping $4.7

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FDA 98

pharmaphorum

JUNE 24, 2021

The FDA has started a review of a new implant version of Roche’s ranibizumab therapy for wet age-related macular degeneration, that could offer patients with the sight-robbing disorder an alternative to monthly eye injections. . Last year, Roche booked around $1.5 Ranibizumab PDS is also under review by the EMA in Europe.

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FDA 95

STAT

MAY 13, 2024

… When it comes to a crucial controversy over pharmaceutical patents, the FDA has been MIA, STAT explains. For Known as the Orange Book, it holds a key, behind-the-scenes role in shaping the competitive landscape of the pharmaceutical industry.

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FDA 89

pharmaphorum

OCTOBER 24, 2021

Roche’s Genentech unit has won FDA approval for Susvimo, an implant for eyesight-robbing disease wet age-related macular degeneration (AMD) that gives patients an alternative to regular injections into the eye. Last year, Roche booked around $1.5 The FDA started a priority review of the drug in July.

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FDA 98

The FDA Law Blog

NOVEMBER 7, 2023

” At least that’s this blogger’s reaction to the recent news that FTC sent out Notice letters to 10 different drug companies about the patent information they list in the Orange Book. As FTC explains in a Press Release , the Agency “challenged more than 100 patents” that it believes are improperly or inaccurately listed in the Orange Book.

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The FDA Law Blog

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. FDA has already been there , of course, with respect to 180-day exclusivity.)

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Pharmaceutical Companies Pharmaceutical Companies FDA 59

The FDA Law Blog

SEPTEMBER 25, 2024

Throughout his illustrious career, Al has been engaged with Hatch-Waxman, even authoring one of the earliest papers providing an account of the law: “ Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness? ” In his new book, “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer,” which will be released (..)

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pharmaphorum

SEPTEMBER 20, 2021

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. Sales reached a peak in 2019, when Roche booked $1.8 billion, but fell back to $1.4

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FDA Labelling 72

STAT

JUNE 25, 2024

Today, STAT published our  annual list of the top books and podcasts  to check out this summer. Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Good morning.

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FDA 89

pharmaphorum

JULY 9, 2021

One of the criticisms levelled at the FDA over its approval of Biogen and Eisai’s Alzheimer’s disease drug Aduhelm was its decision to clear use of the drug in a broader group of patients than was included in clinical trials. ” The post FDA whittles back Aduhelm approval amid concern over broad label appeared first on.

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Labelling FDA 59

STAT

JANUARY 27, 2023

STAT visited 24 vape shops earlier this month in Oxnard, Ventura, Pasadena, El Monte, Carson and West Hollywood — all of which have had bans on flavored vapes on the books for at least a year; most for two or more years. Seventeen of the shops, or 70%, were selling the products anyway.

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FDA 101

The FDA Law Blog

AUGUST 10, 2022

Koblitz — For years , FDA has been wrestling with questions about what patents should be listed in the Orange Book, but, as we have reported, FDA has made little to no progress on addressing those questions. One of those pressing questions that remains unanswered involves the listing of REMS patents in the Orange Book.

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pharmaphorum

AUGUST 3, 2022

The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims is the first to be fully interchangeable with the originator product. Roche has US marketing rights to the drug, and booked $1.3

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FDA Labelling 59

The FDA Law Blog

FEBRUARY 26, 2024

Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.

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FDA Dosage 59

pharmaphorum

JULY 11, 2021

In another twist to the Aduhelm approval tale, FDA’s Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen executives. In the letter, she writes: “FDA’s decisions are far ranging and it is inevitable that some of those decisions will lead to controversy.”

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The FDA Law Blog

SEPTEMBER 23, 2024

Hatch Foundation’s For cheap generic drug prices, you can thank 40 years of Hatch-Waxman We Work For Health’s Hatch-Waxman Act: Celebrating 40 Years of a Balanced and Innovative Drug Ecosystem Tradeoffs’ Race to the Bottom Series FDA CDER Conversations – 40th Anniversary of the Generic Drug Approval Pathway The U.S. Waxman (sadly, Sen.

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FDA Dosage 59

STAT

SEPTEMBER 13, 2024

Or if you prefer to enjoy the great indoors, you could curl up with a good book or binge watch moving pictures on the telly. As with company drug advertisements, social-media posts sponsored by drug makers are required by the FDA to cite the risks. Beaches, lakes and walking trails are beckoning. But be safe.

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Medical Records Insurance Labelling FDA 92

The FDA Law Blog

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. Rather, the FTC questioned whether these patents meet the statutory and regulatory criteria for listing in the Orange Book.

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Dosage FDA 45

The FDA Law Blog

JUNE 12, 2024

The ideal candidate will have a book of business. Our firm culture is collaborative, and the subject matter is intellectually stimulating. Strong verbal and writing skills are required. Strong verbal and writing skills are required. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer.

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Department of Veterans Affairs FDA 59

pharmaphorum

JANUARY 10, 2022

Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from Merck & Co and Eisai. Idorsia has said it expects to be profitable when it starts booking sales of Quviviq and clazosentan alongside its Ponvory royalty stream.

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The FDA Law Blog

JULY 24, 2024

Join us to address emerging and growing areas of concern, including the implementation of the Inflation Reduction Act, FTC’s—and now a District Court’s—attack on Orange Book patent listings, and the proposed use of the Bayh Doyle Act. FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ).

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FDA 52

STAT

JUNE 2, 2023

This is also a fine time to putter around the grounds or sit back with a good book.  Right now, Leqembi and Biogen’s Aduhelm only have accelerated approval from the FDA, and are subject to even more restrictive coverage limits that require patients to be enrolled in a clinical trial to receive the medications. But be safe.

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FDA 89

STAT

MARCH 17, 2023

You could get a head start and book a much-needed getaway, or curl up in front of the telly and binge watch. So far, the rotation includes this , this and this. And what about you? Spring is about to spring, so this may be an opportunity to start tidying up around the castle. Or you could simply plan the rest of your life. But be safe.

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Insurance FDA 92